11/16/2023 0 Comments Anorectal lidocaine cream![]() ![]() ![]() In addition, the following active ingredients may be used in concentrations of less than 50 percent by weight only when used in combinations in accordance with § 346.22 (a), (b), or (n). (a) The following active ingredients may be used as the sole protectant active ingredient in a product if the ingredient as identified constitutes 50 percent or more by weight of the final product. (d) Phenylephrine hydrochloride 0.25 percent. (c) Epinephrine hydrochloride 0.005 to 0.01 percent. (a) Ephedrine sulfate 0.1 to 1.25 percent. The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient. ![]() 346.12 Vasoconstrictor active ingredients. (i) Tetracaine hydrochloride 0.5 to 1 percent. (e) Dyclonine hydrochloride 0.5 to 1 percent. (d) Dibucaine hydrochloride 0.25 to 1 percent. The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient: 346.10 Local anesthetic active ingredients. A drug that causes temporary constriction of blood vessels. A drug that provides a physical barrier, forming a protective coating over skin or mucous membranes. A drug that produces local disappearance of pain, burning, itching, irritation, and/or discomfort by reversibly blocking nerve conduction when applied to nerve tissue in appropriate concentrations. A drug that causes desquamation (loosening) and debridement or sloughing of the surface cells of the epidermis. Topical application of an anorectal drug product to the mucous membrane of the rectum. Topical application of an anorectal drug product to the skin of the perianal area and/or the skin of the anal canal. A drug that is applied topically (externally) to the skin or mucous membranes for a local and limited protein coagulant effect. A topically (externally) applied drug that relieves itching by depressing cutaneous sensory receptors. A drug that is used to relieve symptoms caused by anorectal disorders in the anal canal, perianal area, and/or the lower rectal areas. A topically (externally) applied drug that relieves pain by depressing cutaneous sensory receptors. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 212 unless otherwise noted. (a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. What will I get with the DailyMed RSS feed?ĭailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.ĭailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To receive all DailyMed Updates for the last seven days PIPER METHYSTICUM ROOT (UNII: BOW48C81XP)ĬARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59T元WG5CO)Ģ8500 mg in 1 JAR Type 0: Not a Combination Productĥ6700 mg in 1 JAR Type 0: Not a Combination Productġ13400 mg in 1 JAR Type 0: Not a Combination ProductĬopy the URL below and paste it into your RSS Reader application. LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) ![]()
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